(189 days)
The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.
The sensor is a single use, non-sterile, disposable medical device. When used with the Audicor Adaptor the device is designed to perform the functions of both a standard resting ECG Electrode by acquiring ECG signals and an Electronic Stethoscope by acquiring heart sounds from the surface of a patients skin. The device is intended for use on the surface of an adult patient's skin in the V4 electrode position on the chest.
The provided document describes the Inovise Medical, Inc. Audicor™ Sensor, an ECG Electrode & Heart Sound Transducer. The study conducted for this device is focused on showing its substantial equivalence to predicate devices and its compliance with specified performance standards and biocompatibility requirements.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Audicor™ Sensor seem to be its compliance with specific performance standards and biocompatibility requirements, as well as its functional similarity to predicate devices. The reported device performance is its successful compliance with these.
| Acceptance Criteria & Performance Standard | Reported Device Performance |
|---|---|
| AAMI EC12:2000 (Disposable ECG Electrodes) | The sensor was tested to the applicable requirements... and shown to comply. Laboratory and bench testing indicates compliance to the standard. |
| AAMI EC53:1995 (ECG Cables and Lead Wires) | The sensor was tested to the applicable requirements... and shown to comply. Laboratory and bench testing indicates compliance to the standard. |
| Biocompatibility (Hydrogel - primary patient contact material) | Evaluated for cytotoxicity, primary skin irritation, and delayed dermal contact sensitization. Test results demonstrate that the material was found acceptable. |
| Functional Equivalence (ECG Electrode Functionality) | Performs the functions of a standard resting ECG Electrode. Compared to Kendall Disposable ECG Electrode (K953649) and found to have "ECG Electrode Functionality: Yes". |
| Functional Equivalence (Heart Sound Acquisition) | Performs the functions of an Electronic Stethoscope by acquiring heart sounds. Compared to E-Scope Electronic Stethoscope (K961301) and found to "Acquires Heart Sounds: Yes" and "Uses Microphone: Yes". |
| General Performance and Safety | "Based on the results of the engineering/design level and biocompatibility tests, it is concluded that the sensor performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for any test set or the data provenance (country of origin, retrospective/prospective). The study appears to be primarily focused on laboratory and bench testing of the device itself and biocompatibility testing of its hydrogel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for a test set in the context of diagnostic performance. The evaluation is against compliance with technical standards and biocompatibility, not clinical diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The study is about compliance with engineering standards and biocompatibility, not an assessment of diagnostic performance that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned. The device is a sensor, not an AI-powered diagnostic tool, and the study focuses on its physical and electrical performance and biocompatibility.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a sensor for acquiring physiological signals, not an algorithm. The "standalone" performance refers to the device's ability to meet the specified engineering and biocompatibility standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the defined parameters within the AAMI EC12:2000 and AAMI EC53:1995 standards for ECG electrodes and cables, respectively, and established methodologies for biocompatibility testing (cytotoxicity, primary skin irritation, and delayed dermal contact sensitization). It's essentially compliance with established industry and regulatory standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The study is an evaluation of hardware and material properties.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.